Monday, January 1, 2018

Writing Validation Requests and Validation Plans

At IVT's 4th Annual Validation Week EU, Paul Pluta, Ph.D., explains the process of connecting Stage 1 and Stage 2 of process validation through properly written and well formed validation requests and validation plans. Dr. Pluta discusses the role of R&D in the document's development and demonstrates utilizing these documents for FDA compliance. Comprehensive outlines for both documents are examined.

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Pharmaceutical Validation Documentation Requirements

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